CN116600746A

CN116600746A - Skirt reinforcement member for prosthetic valve device

Info

Publication number: CN116600746A
Application number: CN202180085009.5A
Authority: CN
Inventors: Y·A·达雷卡; B·麦金蒂尔; E·皮尔斯
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2020-12-22
Filing date: 2021-12-15
Publication date: 2023-08-15

Abstract

A prosthesis includes a frame and a skirt coupled to a surface of the frame. The skirt extends over at least one of the plurality of side openings of the frame. The prosthesis further includes a skirt reinforcement member spanning the at least one side opening from a first crown or post edge defining the at least one side opening to a second crown or post edge defining the at least one side opening. The skirt reinforcing member has a first end, a second end and a length therebetween. The first end of the skirt reinforcement member is attached to a first crown or strut edge and the second end of the skirt reinforcement member is attached to a second crown or strut edge. The skirt reinforcement member is attached to the skirt along an unsupported portion of the skirt spanning the at least one side opening.

Description

Skirt reinforcement member for prosthetic valve device

Technical Field

The present technology relates generally to prosthetic valve devices, and more particularly to prosthetic valve devices including a skirt.

Background

The human heart is a four-chamber muscle organ that provides systemic blood circulation during the cardiac cycle. The four main chambers include the right atrium and right ventricle providing the pulmonary circulation and the left atrium and left ventricle providing the systemic circulation with oxygenated blood received from the lungs. To ensure that blood flows through the heart in one direction, there are atrioventricular valves (tricuspid and mitral valves) between the junctions of the atria and ventricles, and semilunar valves (pulmonary and aortic valves) govern the outlet of the ventricles to the lungs and other parts of the body. These valves contain leaflets or cusps that open and close in response to changes in blood pressure caused by the contraction and relaxation of the heart chamber. The valve leaflets separate from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent regurgitation or regurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by injury or defect, may include stenosis and valve dysfunction or regurgitation. For example, valve stenosis narrows and stiffens the valve, which may prevent blood from flowing to the downstream heart chamber at an appropriate flow rate and may cause the heart to work harder to pump blood through the diseased valve. Valve insufficiency or regurgitation can occur when the valve is not fully closed, thereby regurgitating blood and thus causing a decrease in heart efficiency. Valve disease or damage may be congenital, age-related, drug-induced, or in some cases infection-induced, and may result in enlargement, thickening, and loss of elasticity and efficiency of the heart. Some symptoms of heart valve disease may include weakness, shortness of breath, dizziness, syncope, palpitations, anemia, and edema, and thrombosis that may increase the likelihood of stroke or pulmonary embolism. Symptoms may often be severe enough to debilitate and/or life threatening.

Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such heart valve prostheses may be delivered percutaneously via a catheter-based delivery system and deployed at the site of the diseased heart valve. Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the vasculature of a patient. Once positioned at the treatment site, the heart valve prosthesis expands to engage tissue located at the diseased heart valve area, e.g., to hold the heart valve prosthesis in place.

The present disclosure relates to improvements to heart valve prostheses to ensure that the heart valve prostheses have a low profile for transcatheter delivery through the vasculature of a patient.

Disclosure of Invention

According to a first embodiment of the present disclosure, the present disclosure provides a prosthesis having a radially expanded configuration and a radially compressed configuration. The prosthesis includes a frame including a plurality of crowns and a plurality of struts, wherein each crown is formed between a pair of opposing struts. The plurality of crowns and edges of the plurality of struts define a plurality of side openings. The prosthesis further includes a skirt coupled to a surface of the frame. The skirt extends over at least one of the plurality of side openings of the frame. The prosthesis further includes a skirt reinforcement member spanning the at least one side opening from a first crown or post edge defining the at least one side opening to a second crown or post edge defining the at least one side opening. The skirt reinforcing member has a first end, a second end and a length therebetween. The first end of the skirt reinforcement member is attached to a first crown or strut edge and the second end of the skirt reinforcement member is attached to a second crown or strut edge. The skirt reinforcement member is attached to the skirt along an unsupported portion of the skirt spanning the at least one side opening.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure contemplates that the skirt reinforcement member includes a suture forming a plurality of stitches.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure contemplates that the skirt reinforcement member comprises tissue.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure contemplates that the skirt reinforcing member comprises a fabric.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure contemplates that the at least one side opening is substantially diamond-shaped. In one embodiment, each of the plurality of side openings is substantially diamond-shaped. In one embodiment, one end of the frame includes a row of side openings around the circumference of the frame, the row including six to nine side openings.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure proposes that the first end of the skirt reinforcing member is offset from the second end of the skirt reinforcing member such that the skirt reinforcing member is angled relative to the axis of the frame.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure proposes that the first end of the skirt reinforcing member is aligned with the second end of the skirt reinforcing member such that the skirt reinforcing member extends substantially perpendicular relative to the axis of the frame. In one embodiment, the at least one side opening includes a maximum width, and the skirt reinforcement member spans across the at least one side opening at the maximum width. In one embodiment, the frame includes a plurality of nodes, each node being a region where two crowns of the plurality of crowns of the frame meet, and the skirt reinforcement member spans the at least one side opening from one node to another node.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure proposes that the frame includes a row of side openings around a circumference of the frame, and that a skirted reinforcing member spans each side opening of the row of side openings around the circumference of the frame.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure proposes that the frame is an inner frame, and the prosthesis further comprises an outer frame coupled to the inner frame, the outer frame having a diameter greater than the inner frame.

In one aspect of the first embodiment, and in combination with any other aspect herein, the present disclosure proposes that the prosthesis is a heart valve prosthesis, and the prosthesis further comprises a prosthetic valve component disposed within and secured to the frame, the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through the central lumen of the frame. In one embodiment, the heart valve prosthesis is configured to be placed in situ within the mitral valve.

According to a second embodiment of the present disclosure, the present disclosure provides a prosthesis having a radially expanded configuration and a radially compressed configuration. The prosthesis includes a frame including a plurality of crowns and a plurality of struts, wherein each crown is formed between a pair of opposing struts. The plurality of crowns and edges of the plurality of struts define a plurality of side openings. The prosthesis further includes a skirt coupled to a surface of the frame. The skirt extends over at least one of the plurality of side openings of the frame. The prosthesis further includes a skirt reinforcement member circumscribing an outer surface of the frame. The skirt reinforcement member has a diameter substantially the same as the diameter of the frame when the prosthesis is in the radially expanded configuration. The skirt reinforcement member is attached to the skirt along an unsupported portion of the skirt spanning the at least one of the plurality of side openings of the frame, and the skirt reinforcement member is not directly attached to the frame.

In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure proposes that the skirt reinforcing member be a ring of elastomeric material.

In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure proposes that the at least one side opening of the plurality of side openings is substantially diamond-shaped and defined by at least two struts. In one embodiment, each side opening of the plurality of side openings is substantially diamond-shaped and is defined by at least four struts. In one embodiment, one end of the frame includes a row of side openings around the circumference of the frame, the row including six to nine side openings.

In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure proposes that the frame is an inner frame, and the prosthesis further comprises an outer frame coupled to the inner frame, the outer frame having a diameter greater than the inner frame.

In one aspect of the second embodiment, and in combination with any other aspect herein, the present disclosure proposes that the prosthesis is a heart valve prosthesis, and the prosthesis further comprises a prosthetic valve component disposed within and secured to the frame, the prosthetic valve being configured to block blood flow in one direction to regulate blood flow through the central lumen of the frame. In one embodiment, the heart valve prosthesis is configured to be placed in situ within the mitral valve.

The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description and drawings, and from the claims.

Drawings

The foregoing and other features and advantages of the invention will be apparent from the following description of the embodiments herein, as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The figures are not drawn to scale.

Fig. 1 depicts a perspective view of a transcatheter heart valve prosthesis according to one aspect of the present disclosure.

Fig. 2 depicts a perspective view of a valve support of the transcatheter heart valve prosthesis of fig. 1 with a prosthetic valve component secured therein, in accordance with an aspect of the present disclosure.

Fig. 3 depicts an atrial end view of the transcatheter heart valve prosthesis of fig. 1, according to one aspect of the present disclosure.

Fig. 4 depicts a ventricular end view of the transcatheter heart valve prosthesis of fig. 1, in accordance with an aspect of the present disclosure.

Fig. 5 is an enlarged side view of a side opening of the valve support of fig. 2.

Fig. 6A is a perspective atrial end view of the transcatheter heart valve prosthesis shown in fig. 1, according to one aspect of the present disclosure.

Fig. 6B is an atrial end view of the transcatheter heart valve prosthesis shown in fig. 1, according to one aspect of the present disclosure.

Fig. 7A is a side view of a valve support of the transcatheter heart valve prosthesis of fig. 1, wherein the valve support further comprises a plurality of skirt reinforcement members, according to one aspect of the present disclosure.

Fig. 7B is a perspective atrial end view of the valve support of fig. 7A.

Fig. 7C is an enlarged view of a side opening of the valve support of fig. 7A.

Fig. 8A is a side view of the valve support of the transcatheter heart valve prosthesis of fig. 1, wherein the valve support further comprises a plurality of skirt reinforcement members, according to another aspect of the present disclosure.

Fig. 8B is a perspective atrial end view of the valve support of fig. 8A.

Fig. 8C is an enlarged view of a side opening of the valve support of fig. 8A.

Fig. 9A is a side view of the valve support of the transcatheter heart valve prosthesis of fig. 1, wherein the valve support further comprises a plurality of skirt reinforcement members, according to another aspect of the present disclosure.

Fig. 9B is a perspective atrial end view of the valve support of fig. 9A.

Fig. 9C is an enlarged view of a side opening of the valve support of fig. 9A.

Fig. 10A is a side view of the valve support of the transcatheter heart valve prosthesis of fig. 1, wherein the valve support further comprises a plurality of skirt reinforcement members, according to another aspect of the present disclosure.

Fig. 10B is a perspective atrial end view of the valve support of fig. 10A.

Fig. 10C is an enlarged view of a side opening of the valve support of fig. 10A.

Fig. 11A is a side view of the valve support of the transcatheter heart valve prosthesis of fig. 1, wherein the valve support further comprises a plurality of skirt reinforcement members, according to another aspect of the present disclosure.

FIG. 11B is a perspective atrial end view of the valve support of FIG. 11A.

Fig. 11C is an enlarged view of a side opening of the valve support of fig. 11A.

Fig. 12A is a side view of the valve support of the transcatheter heart valve prosthesis of fig. 1, wherein the valve support further comprises a plurality of skirt reinforcement members, according to another aspect of the present disclosure.

Fig. 12B is a perspective atrial end view of the valve support of fig. 12A.

Fig. 12C is an enlarged view of a side opening of the valve support of fig. 12A.

Fig. 13A is a side view of the valve support of the transcatheter heart valve prosthesis of fig. 1, wherein the valve support includes skirt reinforcement members circumscribing an outer surface of the valve support.

Fig. 13B is a top view of the skirt reinforcement member of fig. 13A with the skirt reinforcement member removed from the valve support for illustration purposes only.

Fig. 14 depicts a perspective view of a transcatheter heart valve prosthesis according to another aspect of the present disclosure, wherein the frame further comprises a plurality of skirt reinforcement members.

Fig. 14A is an enlarged view of a side opening of the transcatheter heart valve prosthesis of fig. 14.

Fig. 14B is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in a vertical orientation, according to another embodiment of the present disclosure.

Fig. 14C is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in an angled orientation, according to another embodiment of the present disclosure.

Fig. 15 depicts a perspective view of a transcatheter heart valve prosthesis according to another aspect of the present disclosure, wherein the frame further comprises a plurality of skirt reinforcement members.

Fig. 15A is an enlarged view of a side opening of the transcatheter heart valve prosthesis of fig. 15.

Fig. 15B is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in a vertical orientation, according to another embodiment of the present disclosure.

Fig. 15C is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in an angled orientation, according to another embodiment of the present disclosure.

Fig. 16 depicts a perspective view of a transcatheter heart valve prosthesis according to another aspect of the present disclosure, wherein the frame further comprises a plurality of skirt reinforcement members.

Fig. 16A is an enlarged view of a side opening of the transcatheter heart valve prosthesis of fig. 16.

Fig. 16B is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in a vertical orientation, according to another embodiment of the present disclosure.

Fig. 16C is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in an angled orientation, according to another embodiment of the present disclosure.

Fig. 17 depicts a perspective view of a transcatheter heart valve prosthesis according to another aspect of the present disclosure, wherein the frame further comprises a plurality of skirt reinforcement members.

Fig. 17A is an enlarged view of a side opening of the transcatheter heart valve prosthesis of fig. 17.

Fig. 17B is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in a vertical orientation, according to another embodiment of the present disclosure.

Fig. 17C is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in an angled orientation, according to another embodiment of the present disclosure.

Fig. 17D is an enlarged view of a side opening of a transcatheter heart valve prosthesis according to another embodiment of the present disclosure, wherein two skirt reinforcement members are disposed on a single side opening of the transcatheter valve prosthesis.

Fig. 18 depicts a perspective view of a transcatheter heart valve prosthesis according to another aspect of the present disclosure, wherein the frame further comprises a plurality of skirt reinforcement members.

Fig. 18A is an enlarged view of a side opening of the transcatheter heart valve prosthesis of fig. 18.

Fig. 18B is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in a vertical orientation, according to another embodiment of the present disclosure.

Fig. 18C is an enlarged view of a side opening of a transcatheter heart valve prosthesis with skirt reinforcement members extending in an angled orientation, according to another embodiment of the present disclosure.

Fig. 19 depicts a perspective view of an abutment prosthesis according to another aspect of the present disclosure, wherein the frame of the abutment prosthesis includes a plurality of skirt reinforcement members.

Fig. 19A is an enlarged view of a side opening of the abutment prosthesis of fig. 19.

Fig. 19B is an enlarged view of a side opening of an abutment prosthesis according to another embodiment of the present disclosure, with the skirt reinforcement member extending in a vertical orientation.

Fig. 19C is an enlarged view of a side opening of an abutment prosthesis according to another embodiment of the present disclosure, with the skirt reinforcement member extending in an angled orientation.

Fig. 20 is a perspective view of the abutment prosthesis shown in fig. 19 and a valve prosthesis disposed in the abutment prosthesis.

Detailed Description

Specific embodiments of the present invention will now be described with reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. The terms "distal" and "proximal" are used in the following description in reference to a native vessel, a native valve, or a device to be implanted into a native vessel or native valve (such as a transcatheter heart valve prosthesis), and are described with respect to the direction of blood flow. Thus, "distal" and "distally" refer to positions in a downstream direction with respect to the direction of blood flow, and the terms "proximal" and "proximally" refer to positions in an upstream direction with respect to the direction of blood flow.

Embodiments of the present disclosure relate to a skirt reinforcement member for supporting or reinforcing a skirt that spans a side opening of a stent or frame of a valve prosthesis. The skirt reinforcement member provides a reinforced composite skirt for the valve prosthesis with long term durability and excellent implantation performance. Furthermore, as will be explained in more detail herein, the skirt reinforcement member is configured to prevent bulging (billowing) of the skirt material across the side openings of the frame of the valve prosthesis, as such bulging may undesirably result in contact between the skirt and leaflets of the valve prosthesis after in situ deployment of the valve prosthesis. If the leaflets of the valve prosthesis contact the skirt during in situ opening and closing, such contact may result in early leaflet tissue wear and early skirt wear due to undesirable bulging of the skirt. In addition, the large relative movement between the skirt and the frame may further result in early skirt wear. Early leaflet tissue wear and/or early skirt wear can negatively impact the long-term durability of the valve prosthesis. The skirt reinforcement members disclosed herein strengthen the skirt material across the side openings of the frame of the valve prosthesis to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both the skirt and the leaflets.

Fig. 1-6 illustrate a transcatheter heart valve prosthesis 100 that may be utilized with embodiments of the skirt reinforcement members described herein. A heart valve prosthesis 100 is illustrated herein to aid in describing the present invention. The following description of the transcatheter heart valve prosthesis 100 is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. It should be appreciated that any number of alternative heart valve prostheses may be used with the skirt reinforcement members described herein. Other non-limiting examples of transcatheter heart valve prostheses that may be used with the skirt reinforcement members described herein are described in U.S. application Ser. No. 16/853,851 to McVeigh et al, U.S. patent No. 9,034,032 to McLean et al, and International patent application Ser. No. PCT/US 2014/029549 to McLean et al, U.S. patent application publication No. 2012/0101572 to Kovalsky et al, U.S. patent application publication No. 2012/0035722 to Tuval et al, U.S. patent application publication No. 2006/0265056 to Nguyen et al, U.S. patent application publication No. 2007/05409266 to Birdsall, and U.S. patent application publication No. 2007/05409269 to Dolan et al, each of which are incorporated herein by reference in their entirety. Although transcatheter heart valve prosthesis 100 is a heart valve prosthesis configured for placement within a mitral heart valve, the embodiments of skirt reinforcement members described herein can be used with any valve prosthesis having a skirt. For example, embodiments of skirt reinforcement members described herein may be used with transcatheter heart valves configured for placement within a pulmonary valve, aortic valve, mitral valve, or tricuspid valve, or may be used with transcatheter valve prostheses configured for placement within a venous valve or other in-vivo passageway deemed useful. There is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. Further, the embodiments of skirt reinforcement members described herein may be used with any stent or frame having a skirt that is desirably reinforced to limit bulging, and do not require the stent or frame to include prosthetic valve components disposed therein.

Fig. 1 illustrates a perspective view of a transcatheter heart valve prosthesis 100 according to one aspect of the present disclosure. The transcatheter heart valve prosthesis 100 is configured to be radially compressed into a crimped configuration of reduced diameter for delivery within the vasculature (not shown) and returned to an expanded deployed configuration, as shown in fig. 1. In other words, transcatheter heart valve prosthesis 100 has a crimped configuration for delivery within the vasculature and an expanded configuration for deployment within the native heart valve. In accordance with embodiments of the present disclosure, the transcatheter heart valve prosthesis 100 has a low profile suitable for delivery to and deployment within a native heart valve via a suitable delivery catheter that can be directed to a deployment site of the native heart valve of the heart via any of a transseptal approach, retrograde approach, or transapical approach, when in a crimped configuration. Transcatheter heart valve prosthesis 100 includes a stent or frame 102 and a prosthetic valve component 108 including at least one leaflet disposed within frame 102 and secured to the frame.

Any portion of the frame 102 described herein as an element of the heart valve prosthesis 100 may be made of any number of suitable biocompatible materials, such as stainless steel, nickel titanium alloys (such as Nitinol ^TM ) Cobalt chromium alloys (such as MP 35N), other alloys (such as(Elgin, ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number or combination of other materials. A suitable biocompatible material will be selected to provide a transcatheter heart valve prosthesis 100 that will be configured to be compressed into a crimped configuration of reduced diameter for transcatheter delivery to the native valve, whereby release from the delivery catheter will return the prosthesis to the expanded deployed configuration.

In one aspect of the present disclosure, the frame 102 of the transcatheter heart valve prosthesis 100 includes a valve support 104 at least partially surrounded by and coupled to an anchor element 106. The valve support 104 is a tubular stent-like structure or frame structure defining a central lumen 110 from an inflow end 101 of the valve support 104 to an outflow end 103 of the valve support 104. The valve support 104 is configured to support a prosthetic valve component 108 therein, as will be described in more detail below. In one embodiment, the valve support 104 has a substantially cylindrical shape, wherein the diameter of the outflow end 103 of the valve support 104 is substantially the same as the diameter of the inflow end 101 of the valve support 104.

The valve support 104 includes a skirt 112 coupled to a surface thereof. More particularly, the skirt 112 is coupled to an inner surface of the valve support 104 to line a portion thereof. Alternatively, the skirt 112 may be coupled to an outer surface of the valve support 104 to enclose a portion thereof, as known to those of ordinary skill in the art of prosthetic valve construction. The skirt 112 may be of natural or biological material such as pericardium or another membranous tissue (such as intestinal submucosa). Alternatively, the skirt 112 may be a low porosity woven fabric, such as polyester, dacron, or PTFE, that creates a unidirectional fluid pathway when attached to the stent. In one embodiment, the skirt 112 may be a knitted or woven polyester, such as a polyester or PTFE knit, which may be utilized when it is desired to provide a medium to ingrowth tissue and the ability to stretch the fabric to conform to a curved surface. Polyester velvet fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. For example, these and other suitable cardiovascular fabrics are commercially available from the bard peripheral vascular company (Bard Peripheral Vascular, inc.) of tampei, arizona.

In one aspect of the present disclosure, the anchoring element 106 is a stent-like structure or frame structure that serves as an anchor for the transcatheter heart valve prosthesis 100 to secure its deployed position within the native annulus. The anchoring element 106 is a substantially cylindrical structure configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native mitral valve. At the inflow end 101 of the valve support 104, the anchor element 106 is radially spaced apart from the valve support 104 by a distance S to mechanically isolate the inflow end 101 of the valve support 104 from the anchor element 106. The anchor element 106 includes one or more wedges or prongs 114 extending outwardly from the outside thereof to engage heart tissue. In another embodiment, the anchor elements 106 may employ barbs, spikes, or other tissue fixation mechanisms to engage heart tissue.

The transcatheter heart valve prosthesis 100 further includes a border or rim element 116 extending outwardly from the upstream end of the anchor element 106. The border element 116 comprises overlapping 180 degree out of phase sinusoidal wire forms that are attached and hinged to the anchor element 106 by a suitable biocompatible low profile fabric 117, such as a polyethylene terephthalate (PET) woven fabric, for bioprosthetic implants (i.e., endovascular grafts, heart valves, or left atrial appendage devices) to promote bio-integration. If present, the border element 116 may serve as an atrial retainer, and to perform this function, the border element 116 may be configured to engage tissue above the native annulus, such as the upper surface of the annulus, or some other tissue in the left atrium, to thereby inhibit downstream migration of the prosthetic heart valve 100, for example during atrial contraction.

The prosthetic valve component 108 of the transcatheter heart valve prosthesis 100 is capable of regulating flow therethrough via valve leaflets that can form a replacement valve. Fig. 1-6 illustrate an exemplary prosthetic valve component having three leaflets, but a single leaflet or mitral leaflet configuration may alternatively be used in embodiments of the present disclosure. When deployed in situ, the prosthetic valve component 108 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen 110 of the valve support 104. Fig. 2 depicts a perspective view of the valve support 104 with the prosthetic valve component 108 secured therein, the valve support 104 being shown in fig. 2 removed from the remainder of the transcatheter heart valve prosthesis 100 shown in fig. 1 for ease of illustration. Fig. 3 depicts an atrial end or inflow end view of the transcatheter heart valve prosthesis 100 shown in fig. 1, and fig. 4 depicts a ventricular end or outflow end view of the transcatheter heart valve prosthesis 100 shown in fig. 1. The prosthetic valve component 108 includes valve leaflets 109, e.g., three valve leaflets 109, that are configured to coapt within an upstream portion of the valve support 104, with leaflet commissures 109A, 109B, 109C of the valve leaflets 109 secured within a downstream portion of the valve support 104 such that the valve leaflets 109 open during diastole. The leaflets 109 are attached along their bases to the valve support 104, for example, using sutures or a suitable biocompatible adhesive. An attachment boundary or MOA is formed at the juncture of the leaflet 109 and the valve support 104. Adjacent pairs of leaflets 109 are attached to each other at their lateral ends to form leaflet commissures 109A, 109B, 109C. The orientation of the leaflets 109 within the valve support 104 depends on which end of the transcatheter heart valve prosthesis 100 is the inflow end and which end of the transcatheter heart valve prosthesis 100 is the outflow end, thereby ensuring unidirectional flow of blood through the transcatheter heart valve prosthesis 100.

The valve leaflet 109 can be attached to the skirt 112. The valve leaflet 109 can be formed from a variety of flexible materials including, but not limited to, natural pericardial materials such as bovine, equine, or porcine-derived tissue, or synthetic materials such as Polytetrafluoroethylene (PTFE),Polyester, pyrolytic carbon, or other biocompatible material. For certain prosthetic leaflet materials, it may be desirable to cover one or both sides of the replacement valve leaflet with a material that prevents or minimizes overgrowth. It is further desirable that the prosthetic leaflet material be durable and not stretch, deform or fatigue.

For delivery, the transcatheter heart valve prosthesis 100 is radially compressed on the delivery system into a crimped configuration of reduced diameter for delivery within the vasculature. As known in the art, the delivery system includes an inner shaft that receives the transcatheter heart valve prosthesis 100 on a distal portion thereof, and an outer sheath or outer balloon configured to compressively retain the transcatheter heart valve prosthesis 100 on the distal portion of the inner shaft during delivery. In other words, the outer sheath or outer balloon surrounds and constrains the transcatheter heart valve prosthesis 100 in a radially compressed or crimped configuration. Exemplary delivery systems for delivering the transcatheter heart valve prosthesis 100 are described in U.S. patent No. 9,034,032 to McLean et al and international patent application No. PCT/US 2014/029549 to McLean et al, which documents were previously incorporated herein by reference. However, it will be apparent to those of ordinary skill in the art that other delivery systems may be utilized, and that the components of the delivery system may vary depending on the configuration and structure of the transcatheter valve prosthesis being delivered.

With reference to fig. 2 and 5, the structure of the valve support 104 will now be described in more detail. Fig. 5 is an enlarged side view of the plurality of side openings 118 of the valve support 104. The valve support 104 includes a plurality of crowns 120 and a plurality of struts 122, wherein each crown 120 is formed between a pair of opposing struts 122. Each crown 120 is a curved segment or bend that extends between opposing struts 122. The valve support 104 is tubular, with the plurality of side openings 118 defined by edges of the plurality of crowns 120 and the plurality of struts 122. In one embodiment, the plurality of side openings 118 may be substantially diamond-shaped. The valve support 104 includes a plurality of nodes 121. Node 121 is defined as the region within valve support 104 where two crowns of the plurality of crowns 120 meet or join. As best shown in fig. 5, in this embodiment, the skirt 112 is attached to the inner surface of the valve support 104 around its circumference. The skirt 112 lines the inner surface of the valve support 104 and extends across or over each side opening 118 of the plurality of side openings 118. It is noted that as shown in fig. 5, the skirt 112 is not required to extend over the entire opening of each side opening 118. Indeed, the skirt 112 may span or cover only a portion of the side opening 118, as shown in fig. 5.

A series of endmost inflow crowns 120A are formed at the inflow end 101 of the valve support 104 and a series of endmost outflow crowns 120B are formed at the outflow end 103 of the valve support 104. In one embodiment, the inflow end 101 of the valve support 104 has a total of nine endmost inflow crowns 120A around the circumference of the valve support. The inflow end 101 of the valve support 104 comprises a row of side openings 118 around the circumference of the valve support, and the row has a total of nine side openings 118. Further, the outflow end 103 of the valve support 104 has a total of nine endmost inflow crowns 120B around the circumference of the valve support. The outflow end 103 of the valve support 104 comprises a row of side openings 118 around the circumference of the valve support, and the row has a total of nine side openings 118. In another embodiment of the present disclosure (not shown), each of the inflow end 101 and outflow end 103 of the valve support 104 has six to nine endmost inflow crowns 120A, 120B around the circumference of the valve support, and a row of side openings 118 is included around the circumference of the valve support, the row including six to nine side openings 118.

The width W of the side openings 118 is relatively wide compared to other stents or frames known in the art, thereby resulting in a relatively small total number of side openings 118 around the circumference of the valve support 104. In one embodiment, the width W is between 1/24 and 1/6 of the circumference of the valve support 104, or in other words between 4% and 16% of the circumference of the valve support 104. By increasing the width of the side opening 118, a smaller amount of material is required for the valve support 104 so that a lower profile can be achieved when the valve support 104 is crimped into a radially compressed configuration for delivery. More particularly, because the frame 102 includes both the valve support 104 and the anchor element 106, it is a challenge to reduce the profile of the transcatheter valve prosthesis 100 in a crimped or radially compressed configuration. The challenge in reducing the profile is that the incompressible material of the frame 102 exerts a high compressive force on the soft tissue material of the leaflets 109 in the crimped or radially compressed configuration. Such high compressive forces may alter the integrity of the leaflets 109, thereby affecting the long-term durability of the transcatheter valve prosthesis 100. However, increasing the width W of the side opening 118 provides a reduction in incompressible material of the frame 102, thereby enabling a lower profile in a curled or radially compressed configuration.

However, reducing the incompressible material of the frame 102 means that the skirt 112 spans a longer distance between nodes 121 or struts 122. In other words, as the width of the side opening 118 relatively increases as described above, the amount of material of the skirt 112 across the side opening 118 also increases, and thus a greater amount of skirt 112 material is not attached to the valve support 104. Referring now to fig. 6A and 6B, as an increased amount of skirt 112 material spans side opening 118, the chance of skirt 112 bulging or moving radially inward toward leaflet 109 as indicated by directional arrow 124 increases. The skirt 112 may bulge during valve in situ opening and closing, and the leaflets 109 may contact the skirt 112. Such bulging may undesirably result in contact between the skirt 112 and the leaflets 109 of the transcatheter heart valve prosthesis 100. If the leaflets 109 of the transcatheter heart valve prosthesis 100 contact the skirt 112 during opening and closing, such contact may result in early leaflet tissue wear and early skirt wear. Furthermore, the large relative movement between the skirt 112 and the valve support 104 may further result in early skirt wear.

Embodiments of the present disclosure relate to skirt reinforcement members that reinforce the skirt 112 material across the side openings 118 of the valve support 104 to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both the skirt 112 and the leaflets 109. For purposes of illustration, the skirt reinforcement members described herein are incorporated onto the valve support 104, the structure of the valve support 104 having been described in detail above. However, as previously mentioned, the skirt reinforcement members described herein may be incorporated into any stent or frame having a skirt that requires reinforcement to limit bulging, and does not require the stent or frame to include prosthetic valve components disposed therein.

Turning to fig. 7A and 7B, a skirt reinforcement member 1330 in accordance with one aspect of the present disclosure is illustrated. More particularly, fig. 7A and 7B are side and stereoscopic atrial end views, respectively, of valve support 104 including a plurality of skirt reinforcement members 730. In the embodiment of fig. 7A and 7B, the valve support 104 includes a row of side openings 118 around its circumference, and a skirt reinforcement member 730 extends across or over each side opening 118 of the row of side openings 118 around the circumference of the valve support 104. However, it is not required that a skirt reinforcement member 730 be used on each side opening 118 of the row of side openings 118 around the circumference of the valve support 104. Indeed, the skirt reinforcement member 730 may be used only on side openings 118 having skirt material that may contact the leaflets 109 as the leaflets open and close in situ. According to one aspect of the present disclosure, the at least one side opening 118 must include a skirt reinforcement member 730. Each skirt reinforcement member 730 spans the side opening 118 from a first crown or strut edge defining the at least one side opening 118 to a second crown or strut edge defining the at least one side opening 118.

In the embodiment of fig. 7A and 7B, each skirt reinforcing member 730 is a suture filament or strand 731 forming a plurality of stitches 740. Exemplary suture materials include, but are not limited to, monofilaments or plastic suture materials, such as polypropylene. Each skirt reinforcing member 730 is configured to limit or prevent bulging or radial movement of the skirt 112 across or extending over the respective side opening 118. More particularly, each skirt reinforcing member 730 has a first end 732, a second end 734, and a length L therebetween. Skirt reinforcement member 730, including the plurality of stitches 740, is directly attached to skirt 112 along its length L. In other words, the skirt reinforcing members 730 are directly attached to the skirt 112 along an unsupported portion of the skirt 112 spanning the respective side opening 118. As used herein, "unsupported portion of the skirt" refers to the areas of the skirt 112 where the surface of the skirt does not directly contact or abut the valve support 104. The plurality of stitches 740 of skirt reinforcement member 730 extend or weave through the material of skirt 112 to ensure that skirt reinforcement member 730 applies tension to skirt 112 and thereby prevents undesirable bulging of the skirt material.

The first end 732 of the skirt reinforcement member 730 is attached to a first edge 736 defining the respective side opening 118 and the second end 734 of the skirt reinforcement member 730 is attached to a second or opposite edge 738 defining the respective side opening 118. Attaching the first end 732 and the second end 734 of the skirt reinforcement member 730 to the valve support 104 ensures that the skirt reinforcement member 730 has sufficient rigidity to apply tension to the skirt 112 and prevent bulging. More particularly, the first and second ends 732, 734 of the skirt reinforcement member 730 are attached to the valve support 104 such that the skirt reinforcement member 730 has sufficient stretch along its length L to minimize radial movement of the skirt 112 throughout the cardiac cycle.

As will be described in greater detail herein, the first end 732 and the second end 734 of the skirt reinforcement member 730 can be attached to the crown 120 or post 122 of the valve support 104. In other words, the first edge 736 and the second edge 738 defining the respective side openings 118 may be edges of the crown 120 or the struts 122 of the valve support. In the embodiment depicted in fig. 7A and 7B, the first end 732 of the skirt reinforcement member 730 is in contact with the skirt reinforcement memberThe second end 734 of the member 730 is circumferentially aligned such that the skirt reinforcement member 732 is relative to the axis L of the valve support 104 _A Extending substantially vertically. Skirt reinforcement member 730 extends centrally or centrally over side opening 118 such that skirt reinforcement member 730 extends across or over side opening 118 at maximum width MW of side opening 118. Skirt reinforcement member 730 spans side opening 118 from one node 121 to another node 121 of valve support 104.

In the embodiment depicted in fig. 7A and 7B, adjacent skirt reinforcement members 730 are circumferentially aligned such that the skirt reinforcement members 730 collectively circumscribe the valve support 104. However, circumferential alignment of adjacent skirt reinforcement members 730 is not required, and further, each side opening 118 is not required to include a skirt reinforcement member as described above.

Other placements of the skirt reinforcing member are also contemplated herein. For example, in the embodiment depicted in fig. 8A and 8B, the first end 832 of the skirt reinforcement member 830 is circumferentially offset from the second end 834 of the skirt reinforcement member 830 such that the skirt reinforcement member 830 is relative to the axis L of the valve support 104 _A Angled. The first end 832 of the skirt reinforcement member 830 is attached to a first edge 836 defining the respective side opening 118 and the second end 834 of the skirt reinforcement member 830 is attached to a second or opposite edge 838 defining the respective side opening 118. Skirt reinforcement member 830 diagonally spans side opening 118 from the top end of one node 121 to the bottom end of another node 121 of valve support 104, or alternatively, diagonally spans side opening 118 from node 121 to post 122 of valve support 104. In the embodiment depicted in fig. 8A and 8B, adjacent skirt reinforcement members 830 have alternating orientations (i.e., diagonally downward and diagonally upward) such that the first ends 832 of the skirt reinforcement members 830 are circumferentially aligned with the second ends 834 of the adjacent skirt reinforcement members 830, and the skirt reinforcement members 830 collectively circumscribe the valve support 104 in a zigzag configuration. However, it is not required that adjacent skirt reinforcement members 830 have alternating orientations, and further, that each side opening 118 include a skirt reinforcement member as described above.

Another implementation depicted in fig. 9A and 9BIn an example, a first end 932 of skirt reinforcement member 930 is aligned with a second end 934 of skirt reinforcement member 930 such that, similar to skirt reinforcement member 730 described above, skirt reinforcement member 932 is aligned with respect to axis L of valve support 104 _A Extending substantially vertically. The first end 932 of the skirt reinforcement member 930 is attached to a first edge 936 defining the respective side opening 118 and the second end 934 of the skirt reinforcement member 930 is attached to a second or opposite edge 938 defining the respective side opening 118. However, in the embodiment of fig. 9A and 9B, skirt reinforcement member 930 extends in a lower region above side opening 118, the width W2 of the lower region being less than the maximum width MW. Thus, the skirt reinforcement member 930 extends across or over the side opening 118 at the width W2 of the side opening. The skirt reinforcement member 930 spans the side opening 118 from one node 121 to another node 121 of the valve support 104, or alternatively, may span the side opening 118 from one leg 122 to another leg 122 of the valve support 104. In the embodiment depicted in fig. 9A and 9B, adjacent skirt reinforcement members 930 are circumferentially aligned such that the skirt reinforcement members 930 collectively circumscribe the valve support 104. However, circumferential alignment of adjacent skirt reinforcement members 930 is not required, and further, each side opening 118 is not required to include a skirt reinforcement member as described above.

While the above embodiments depict skirt reinforcing members 730, 830, 930 having a generally linear or straight configuration within side openings 118, other configurations of skirt reinforcing members are also contemplated herein. For example, skirt reinforcing members 730, 830, 930 may have a wavy, sinusoidal, or zigzag configuration along their length, or may be configured in a "T" or "X" shape within side opening 118.

Turning to fig. 10A and 10B, a skirt reinforcement member 1030 in accordance with another aspect of the present disclosure is illustrated. More particularly, fig. 10A and 10B are side and stereoscopic atrial end views, respectively, of a valve support 104 including a plurality of skirt reinforcement members 1030. In the embodiment of fig. 10A and 10B, the valve support 104 includes a row of side openings 118 around its circumference, and the skirt reinforcement member 1030 extends across or over each side opening 118 of the row of side openings 118 around the circumference of the valve support 104. However, the use of skirt reinforcement members 1030 on each side opening 118 of the row of side openings 118 around the circumference of the valve support 104 is not required. Indeed, the skirt reinforcement member 1030 may be used only on side openings 118 that have skirt material that may contact the leaflets 109 as they open and close in situ. According to one aspect of the present disclosure, the at least one side opening 118 must include a skirt reinforcement member 1030. Each skirt reinforcement member 1030 spans the side opening 118 from a first crown or strut edge defining the at least one side opening 118 to a second crown or strut edge defining the at least one side opening 118.

Each skirt reinforcement member 1030 is similar to skirt reinforcement member 730 except that each skirt reinforcement member 1030 further includes a fabric or tissue strip 1042 in addition to the seaming filaments or strands 1031 forming the plurality of stitches 1040. The strap 1042 is attached to the skirt 112 via the plurality of pins 1040 and can be disposed on an outer or inner surface of the skirt 112. Thus, in addition to the plurality of stitches 1040 formed from the suture, skirt reinforcement member 1030 further includes a tissue or fabric strip 1042 and thus provides stronger support or reinforcement than skirt reinforcement member 730 described above that includes only the plurality of stitches 740 formed from the suture.

Similar to skirt reinforcement members 730, each skirt reinforcement member 1030 is configured to limit or prevent bulging or radial movement of skirt 112 extending across or over a respective side opening 118. More particularly, each skirt reinforcing member 1030 has a first end 1032, a second end 1034, and a length L therebetween. The length L of skirt reinforcement member 1030, including the plurality of stitches 1040 and one or more tissue or fabric strips 1042, is directly attached to skirt 112 along its length L. In other words, the skirt reinforcement member 1030 is directly attached to the skirt 112 along an unsupported portion of the skirt 112 spanning the respective side opening 118. The plurality of stitches 1040 of skirt reinforcement member 1030 extend or weave through the material of skirt 112 and through the material of tissue or fabric strip 1042 to ensure that skirt reinforcement member 1030 imparts stretch to skirt 112 and thereby prevents undesirable bulging of the skirt material.

The first end 1032 of the skirt reinforcement member 1030 is formed from the seaming strands 1031 of the skirt reinforcement member 1030 and attached to the first edge 1036 defining the respective side opening 118. The second end 1034 of the skirt reinforcement member 1030 is also formed from the seaming strands 1031 of the skirt reinforcement member 1030 and attached to a second or opposite edge 1038 defining the respective side opening 118. Attaching the first end 1032 and the second end 1034 of the skirt reinforcement member 1030 to the valve support 104 ensures that the skirt reinforcement member 1030 has sufficient rigidity to apply tension to the skirt 112 and prevent bulging. More particularly, the first and second ends 1032, 1034 of the skirt reinforcement member 1030 are attached to the valve support 104 such that the skirt reinforcement member 1030 has sufficient stretch along its length L to minimize radial movement of the skirt 112 throughout the cardiac cycle.

The first end 1032 and the second end 1034 of the skirt reinforcement member 1030 may be attached to the crown 120 or post 122 of the valve support 104. In other words, the first and second edges 1036, 1038 defining the respective side openings 118 may be edges of the crown 120 or the struts 122 of the valve support. In the embodiment depicted in fig. 10A and 10B, the first end 1032 of the skirt reinforcement member 1030 is aligned with the second end 1034 of the skirt reinforcement member 1030 such that the skirt reinforcement member 1032 is aligned with respect to the axis L of the valve support 104 _A Extending substantially vertically. Skirt reinforcement member 1030 extends centrally or centrally over side opening 118 such that skirt reinforcement member 1030 extends across or over side opening 118 at maximum width MW of side opening 118. Skirt reinforcement member 1030 spans side opening 118 from one node 121 to another node 121 of valve support 104.

The strap 1042 may be a natural or biological material such as pericardium or another membranous tissue (such as intestinal submucosa). Alternatively, the strap 1042 may be a low porosity woven or knitted fabric such as polyester, dacron or PTFE knit. Exemplary suture materials for the strands 1031 include, but are not limited to, monofilaments or plastic suture materials, such as polypropylene.

The strap 1042 is relatively thin and has a thickness of between 0.1mm and 0.5mm and a height (in the axial direction of the valve support 104) of between 0.2mm and the entire height of the side opening 118. The length of each strap 1042 is substantially the same as the length L of the strap stiffening member 1030 such that the strap 1042 extends substantially between the first end 1032 and the second end 1034 of the strap stiffening member 1030.

In another embodiment, instead of the plurality of stitches 1040, a fabric or tissue strip 1042 may be attached to the skirt 112 with a different securing mechanism. For example, in another embodiment, a fabric or tissue strip 1042 may be attached to the skirt 112 using an adhesive. When an adhesive is utilized as the securing mechanism, fabric or tissue strips 1042 are provided to the skirt in a tensioned configuration to ensure that the skirt reinforcing members 1030 apply tension to the skirt 112 and thereby prevent unwanted bulging of the skirt material. Further, the adhesive may shrink upon curing, thereby imparting further stretch to the skirt material. The adhesive as a securing mechanism provides more predictable compression or folding of the valve support 104 as the valve support 104 collapses into a radially compressed or crimped configuration for delivery.

In the embodiment depicted in fig. 10A and 10B, adjacent skirt reinforcement members 1030 are circumferentially aligned such that the skirt reinforcement members 1030 collectively circumscribe the valve support 104. However, circumferential alignment of adjacent skirt reinforcement members 1030 is not required, and further, each side opening 118 is not required to include a skirt reinforcement member as described above.

Other placements of skirt reinforcement member 1030 are also contemplated herein. For example, in the embodiment depicted in fig. 11A and 11B, the first end 1132 of the skirt reinforcement member 1130 is offset from the second end 1134 of the skirt reinforcement member 1130 such that the skirt reinforcement member 1130 is opposite the axis L of the valve support 104 _A Angled. The first end 1132 of the skirt reinforcement member 1130 is attached to a first edge 1136 defining the respective side opening 118 and the second end 1134 of the skirt reinforcement member 1130 is attached to a second or opposite edge 1138 defining the respective side opening 118. Skirt reinforcement member 1130 is diagonally positioned from the top end of one node 121 to the bottom end of another node 121 of valve support 104Across the side opening 118, or alternatively, diagonally across the side opening 118 from the node 121 to the post 122 of the valve support 104. In the embodiment depicted in fig. 11A and 11B, adjacent skirt reinforcement members 1130 have alternating orientations (i.e., diagonally downward and diagonally upward) such that the first ends 1132 of the skirt reinforcement members 1130 are circumferentially aligned with the second ends 1134 of the adjacent skirt reinforcement members 1130, and the skirt reinforcement members 1130 collectively circumscribe the valve support 104 in a zigzag configuration. However, it is not required that adjacent skirt reinforcement members 1130 have alternating orientations, and further, that each side opening 118 include skirt reinforcement members as described above.

In another embodiment depicted in fig. 12A and 12B, a first end 1232 of skirt reinforcement member 1230 is aligned with a second end 1234 of skirt reinforcement member 1230 such that, similar to skirt reinforcement member 1030 described above, skirt reinforcement member 1232 is aligned with respect to axis L of valve support 104 _A Extending substantially vertically. The first end 1232 of the skirt reinforcement member 1230 is attached to a first edge 1236 defining the respective side opening 118 and the second end 1234 of the skirt reinforcement member 1230 is attached to a second or opposite edge 1238 defining the respective side opening 118. However, in the embodiment of fig. 12A and 12B, skirt reinforcement member 1230 extends in a lower region over side opening 118, the width W2 of the lower region being less than maximum width MW. Accordingly, skirt reinforcement member 1230 extends across or over side opening 118 at width W2 thereof. The skirt reinforcement member 1230 spans the side opening 118 from one node 121 to another node 121 of the valve support 104, or alternatively, may span the side opening 118 from one post 122 to another post 122 of the valve support 104. In the embodiment depicted in fig. 12A and 12B, adjacent skirt reinforcement members 1230 are circumferentially aligned such that the skirt reinforcement members 1230 collectively circumscribe the valve support 104. However, circumferential alignment of adjacent skirt reinforcement members 1230 is not required, and further, each side opening 118 is not required to include a skirt reinforcement member as described above.

While the above embodiments depict skirt reinforcing members 1030, 1130, 1230 having a generally linear or straight configuration, other configurations of skirt reinforcing members are also contemplated herein. For example, the skirt reinforcing members 1030, 1130, 1230 may have a wavy, sinusoidal, or zigzag configuration along their length, or may be configured in a "T" or "X" shape within the side opening 118.

Turning now to fig. 13A and 13B, a skirt reinforcement member 1330 in accordance with another aspect of the present disclosure is illustrated. More particularly, fig. 13A is a side view of the valve support 104 including the skirt reinforcement member 1330, and fig. 13B shows a top view of the skirt reinforcement member 1330 removed from the valve support 104 for illustration purposes. In the embodiment of fig. 13A and 13B, the skirt reinforcement member 1330 is a continuous band or ring 1344 that extends 360 ° around the outer surface 105 of the valve support 104. In other words, the skirt reinforcement member 1330 is disposed circumferentially around the perimeter of the valve support 104 and encircles or circumscribes the outer surface 105 of the valve support 104. The ring 1344 is an elastic material and the diameter D1 of the skirt reinforcement member 1330 is substantially the same as the diameter D2 of the valve support 104 when the valve support 104 is in its radially expanded configuration.

Notably, the ring 1344 is directly attached to the skirt 112 along the side openings 118 of the skirt 112 across or extending over the valve support 104, but the ring 1344 is not directly attached to the valve support 104. In other words, when the ring 1344 and the valve support 104 meet or intersect, the ring 1344 overlaps or overlies the valve support 104, but is not otherwise attached to the valve support. However, the ring 1344 is attached to the skirt 112 to apply tension to the skirt 112 and thereby limit or prevent bulging of the skirt 112 across or extending over the side openings 118 of the valve support 104. Thus, when the ring 1344 and the skirt 112 meet or intersect, the ring 1344 overlaps or overlies the skirt 112 and is further directly attached to the skirt. Because the ring 1344 is directly attached to the skirt 112, is formed of an elastic material, and has a diameter D that is approximately the same as the post-expansion diameter of the valve support 104, the skirt reinforcement member 1330 has sufficient stretch to minimize radial movement of the skirt 112 throughout the cardiac cycle. In this way, the skirt reinforcement member 1330 is configured to minimize radial movement of the skirt 112 and better protect the leaflets 109 from wear and prevent degradation of the skirt.

The ring 1344 may be attached to the skirt 112 via any suitable attachment mechanism, including but not limited to stitching, adhesive, or welding. Suitable elastic materials for the ring 1344 include, but are not limited to, polymeric materials such as polyurethane or silicone, as well as biological or natural materials such as pericardium or another membranous tissue (such as intestinal submucosa). As used herein, "elastic" includes materials that can be stretched or elongated to fit over and around the outer surface 105 of the valve support 104 while also having sufficient resiliency to return to their original size/configuration and conform to the outer surface 105 of the valve support 104. The elastic material of the ring 1344 has sufficient resiliency to conform to and be secured to the outer surface 105 of the valve support 104, but does not exert forces that could cause the inner diameter of the valve support 104 to contract or decrease.

As described above, the skirt reinforcement members 730, 830, 930, 1030, 1130, 1230, 1330 may be used on any transcatheter heart valve prosthesis that includes a skirt on a portion. The skirt reinforcing members 730, 830, 930, 1030, 1130, 1230, 1330 serve to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both the skirt and the leaflets. The specific placement of the skirt reinforcement member may vary depending on the configuration of the frame. In one embodiment, the skirt reinforcement member is positioned downstream of an attachment boundary (MOA) of the leaflets of the transcatheter heart valve prosthesis and on a side opening of a frame that includes skirt material on a portion thereof. The configuration of the frame and the configuration of the side openings of the frame are non-limiting and may vary, as exemplified in the following figures.

Fig. 14 depicts a perspective view of a transcatheter heart valve prosthesis 1400 according to another aspect of the present disclosure. Transcatheter heart valve prosthesis 1400 includes a stent or frame 1402 and a prosthetic valve component 1408 including at least one leaflet disposed within and secured to frame 1402. The frame 1402 includes a plurality of crowns 1420 and a plurality of struts 1422, wherein each crown 1420 is formed between a pair of opposing struts 1422. Each crown 1420 is a curved segment or bend that extends between opposing struts 1422. The frame 1402 is tubular with the plurality of side openings 1418 defined by edges of the plurality of crowns 1420 and the plurality of struts 1422. In one embodiment, the plurality of side openings 1418 may be substantially diamond-shaped.

The frame 1402 includes a skirt 1412 coupled to a surface thereof. More particularly, the skirt 1412 is coupled to an inner surface of the frame 1402 to line a portion thereof. Alternatively, the skirt 1412 may be coupled to an outer surface of the frame 1402 to enclose a portion thereof, as known to those of ordinary skill in the art of prosthetic valve construction. The skirt 1412 may be formed of the same materials as described above with respect to the skirt 112.

The prosthetic valve component 1408 of the transcatheter heart valve prosthesis 1400 is capable of regulating flow therethrough via valve leaflets that can form a replacement valve. Fig. 14 illustrates an exemplary prosthetic valve component having three leaflets 1409, but a single leaflet or mitral leaflet configuration can alternatively be used in embodiments of the present disclosure. As described above with respect to the prosthetic valve component 108, the prosthetic valve component 1408 in the closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen of the frame 1402 when deployed in situ.

Valve leaflet 1409 can be attached to skirt 1412. The skirt 1412 may bulge during valve in situ opening and closing, and the leaflets 1409 may contact the skirt 1412. Such bulging may undesirably result in contact between the skirt 1412 of the transcatheter heart valve prosthesis 1400 and the leaflets 1409. If the leaflets 1409 of the transcatheter heart valve prosthesis 1400 contact the skirt 1412 during opening and closing, such contact may result in early leaflet tissue wear and early skirt wear. In addition, the large relative movement between the skirt 1412 and the frame 1402 may further result in early skirt wear. Accordingly, transcatheter heart valve prosthesis 1400 further includes a plurality of skirt reinforcement members 1430. As described above with respect to the skirt reinforcement member 730, the skirt reinforcement member 1430 reinforces the skirt 1412 material across the side opening 1418 of the frame 1402 to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both the skirt 1412 and the leaflets 1409.

In the embodiment of fig. 14, the frame 1402 includes a row of side openings 1418 around its circumference, and the skirt reinforcement member 1430 extends across or over each side opening 1418 of the row of side openings 1418 around the circumference of the frame 1402. However, it is not required that the skirt reinforcement member 1430 be used on each side opening 1418 of the row of side openings 1418 around the circumference of the frame 1402. Indeed, the skirt reinforcement member 1430 may be used only on side openings 1418 that have skirt material that may come into contact with the leaflets 1409 as the leaflets open and close in situ. In accordance with one aspect of the present disclosure, at least one side opening 1418 must include a skirt reinforcement member 1430. Further, the placement of the skirt reinforcement member 1430 is exemplary only, and the skirt reinforcement member 1430 may be disposed on side openings 1418 in a different row than depicted in fig. 14.

Fig. 14A is an enlarged view of a side opening 1418 of the frame 1402 including a skirt reinforcing member 1430. Each skirt reinforcement member 1430 spans the side opening 1418 from a first crown or strut edge defining the at least one side opening 1418 to a second crown or strut edge defining the at least one side opening 1418. In the embodiment of fig. 14-14A, skirt reinforcement member 1430 is identical to skirt reinforcement member 730. Each skirt reinforcement member 1430 is a suture filament or strand 1431 that forms a plurality of stitches 1440. Skirt reinforcement members 1430 are attached directly to the skirt 1412 along unsupported portions of the skirt 1412 spanning the respective side openings 1418. The plurality of stitches 1440 of the skirt reinforcement member 1430 extend or weave through the material of the skirt 1412 to ensure that the skirt reinforcement member 1430 applies tension to the skirt 1412 and thereby prevents unwanted bulging of the skirt material. The first and second ends 1432, 1434 of the skirt reinforcement member 1430 are attached to the frame 1402 such that the skirt reinforcement member 1430 has sufficient tension along its length to minimize radial movement of the skirt 1412 throughout the cardiac cycle.

In fig. 14 and 14A, skirt reinforcement member 1430 is centered or centered on side opening 1418 in a horizontal orientation Extending therebetween. However, other placements of the skirt reinforcing member are also contemplated herein. For example, in the embodiment depicted in fig. 14B, skirt reinforcement member 1430B extends centrally or centrally over side opening 1418 in a vertical orientation. The first end 1432B of the skirt reinforcement member 1430B is longitudinally offset from the second end 1434B of the skirt reinforcement member 1430B such that the skirt reinforcement member 1430B is relative to the axis L of the frame _A Parallel or substantially parallel. The first end 1432B of the skirt reinforcement member 1430B is attached to a first crown 1420B defining a respective side opening 1418 and the second end 1434B of the skirt reinforcement member 1430 is attached to a second or opposite crown 1420B defining a respective side opening 1418 such that the skirt reinforcement member 1430B spans vertically across the side opening 1418.

In another embodiment depicted in fig. 14C, a first end 1432C of the skirt reinforcement member 1430C is circumferentially offset from a second end 1434C of the skirt reinforcement member 1430C such that the skirt reinforcement member 1430C is relative to the axis L of the frame _A Angled. The first end 1432C of the skirt reinforcement member 1430C is attached to a first edge 1436C defining a respective side opening 1418 and the second end 1434C of the skirt reinforcement member 1430C is attached to a second or opposite edge 1438C defining a respective side opening 1418. Adjacent skirt reinforcement members 1430C may have alternating orientations (i.e., diagonally downward and diagonally upward) such that the skirt reinforcement members 1430C collectively circumscribe the frame in a zigzag configuration. However, it is not required that adjacent skirt reinforcement members 1430C have alternating orientations, and further, that each side opening 1418 include skirt reinforcement members as described above.

Similar to the skirt reinforcement members 1030, 1130, 1230 described above, the skirt reinforcement members 1430, 1430B, 1430C may include fabric or tissue strips in addition to the suture filaments or strands forming the plurality of stitches. Further, instead of the plurality of skirt reinforcement members 1430, the transcatheter heart valve prosthesis 1400 may include a continuous band or ring extending 360 ° around the outer surface of the frame 1402. The ring will be attached to skirt 1412 and may be identical to skirt stiffening member 1330 described above. As shown in fig. 14 with respect to skirt reinforcement member 1430, the ring will be positioned over the same row of side openings 1418.

Fig. 15 depicts a perspective view of a transcatheter heart valve prosthesis 1500 in accordance with another aspect of the present disclosure. Transcatheter heart valve prosthesis 1500 includes a stent or frame 1502 and a prosthetic valve component 1508 including at least one leaflet disposed within frame 1502 and secured to the frame. The frame 1502 includes a plurality of crowns 1520 and a plurality of struts 1522, wherein each crown 1520 is formed between a pair of opposing struts 1522. Each crown 1520 is a curved section or bend that extends between opposing struts 1522. The frame 1502 is tubular with the plurality of side openings 1518 defined by edges of the plurality of crowns 1520 and the plurality of struts 1522. In one embodiment, the plurality of side openings 1518 may be substantially hexagonal.

The frame 1502 includes a skirt 1512 coupled to a surface thereof. More particularly, the skirt 1512 is coupled to an inner surface of the frame 1502 to line a portion thereof. Alternatively, the skirt 1512 may be coupled to the outer surface of the frame 1502 to enclose a portion thereof, as known to those of ordinary skill in the art of prosthetic valve construction. The skirt 1512 may be formed from the same materials as described above with respect to the skirt 112.

The prosthetic valve component 1508 of the transcatheter heart valve prosthesis 1500 is capable of regulating flow therethrough via valve leaflets that can form a replacement valve. Fig. 15 illustrates an exemplary prosthetic valve component having three leaflets 1509, but a single leaflet or mitral leaflet configuration may alternatively be used in embodiments of the present disclosure. As described above with respect to the prosthetic valve component 108, the prosthetic valve component 1508 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen of the frame 1502 when deployed in situ.

The valve leaflets 1509 can be attached to the skirt 1512. The skirt 1512 may bulge during valve in situ opening and closing, and the leaflets 1509 may contact the skirt 1512. Such bulging may undesirably result in contact between the skirt 1512 and the leaflets 1509 of the transcatheter heart valve prosthesis 1500. If the leaflets 1509 of the transcatheter heart valve prosthesis 1500 contact the skirt 1512 during opening and closing, such contact may result in early leaflet tissue wear and early skirt wear. Furthermore, the large relative movement between the skirt 1512 and the frame 1502 may further result in early skirt wear. Accordingly, transcatheter heart valve prosthesis 1500 further includes a plurality of skirt reinforcement members 1530. As described above with respect to the skirt reinforcement member 730, the skirt reinforcement member 1530 reinforces the skirt 1512 material across the side openings 1518 of the frame 1502 to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both the skirt 1512 and the leaflets 1509.

In the embodiment of fig. 15, the frame 1502 includes a row of side openings 1518 around its circumference, and the skirt reinforcement member 1530 extends across or over each side opening 1518 of the row of side openings 1518 around the circumference of the frame 1502. However, it is not required that a skirt reinforcement member 1530 be used on each side opening 1518 of the row of side openings 1518 around the circumference of the frame 1502. Indeed, the skirt reinforcement member 1530 may be used only on side openings 1518 that have skirt material that may contact the leaflets 1509 as the leaflets open and close in situ. According to one aspect of the present disclosure, at least one side opening 1518 must include a skirt reinforcement member 1530. Further, the placement of the skirt reinforcement member 1530 is merely exemplary, and the skirt reinforcement member 1530 may be disposed on a side opening 1518 in a different row than depicted in fig. 15.

Fig. 15A is an enlarged view of a side opening 1518 of the frame 1502 including the skirt reinforcement member 1530. Each skirt reinforcement member 1530 spans the side opening 1518 from a first crown or post edge defining the at least one side opening 1518 to a second crown or post edge defining the at least one side opening 1518. In the embodiment of fig. 15-15A, skirt reinforcement member 1530 is identical to skirt reinforcement member 730. Each skirt reinforcement member 1530 is a suture filament or strand 1531 that forms a plurality of stitches 1540. Skirt reinforcement members 1530 are attached directly to the skirt 1512 along unsupported portions of the skirt 1512 spanning the respective side openings 1518. The plurality of stitches 1540 of the skirt reinforcement member 1530 extend or weave through the material of the skirt 1512 to ensure that the skirt reinforcement member 1530 applies tension to the skirt 1512 and thereby prevent unwanted bulging of the skirt material. The first end 1532 and the second end 1534 of the skirt reinforcement member 1530 are attached to the frame 1502 such that the skirt reinforcement member 1530 has sufficient tension along its length to minimize radial movement of the skirt 1512 throughout the cardiac cycle.

In fig. 15 and 15A, the skirt reinforcement member 1530 extends centrally or midway over the side opening 1518 in a horizontal orientation. However, other placements of the skirt reinforcing member are also contemplated herein. For example, in the embodiment depicted in fig. 15B, the skirt reinforcement member 1530B extends centrally or midway over the side opening 1518 in a vertical orientation. The first end 1532B of the skirt reinforcement member 1530B is longitudinally offset from the second end 1534B of the skirt reinforcement member 1530B such that the skirt reinforcement member 1530B is relative to the frame axis L _A Parallel or substantially parallel. The first end 1532B of the skirt reinforcement member 1530B is attached to a first crown 1520B defining a respective side opening 1518 and the second end 1534B of the skirt reinforcement member 1530 is attached to a second or opposite crown 1520B defining a respective side opening 1518 such that the skirt reinforcement member 1530B spans vertically across the side opening 1518.

In another embodiment depicted in fig. 15C, the first end 1532C of the skirt reinforcement member 1530C is circumferentially offset from the second end 1534C of the skirt reinforcement member 1530C such that the skirt reinforcement member 1530C is relative to the frame axis L _A Angled. The first end 1532C of the skirt reinforcement member 1530C is attached to a first edge 1536C defining a respective side opening 1518 and the second end 1534C of the skirt reinforcement member 1530C is attached to a second or opposite edge 1538C defining a respective side opening 1518. Adjacent skirt reinforcement members 1530C may have alternating orientations (i.e., diagonally downward and diagonally upward) such that the skirt reinforcement members 1530C collectively circumscribe the frame in a zigzag configuration. However, adjacent skirt reinforcement members 1530C are not required to have alternating orientations, and further, each side opening 1518 is not required to include a skirt reinforcement member as described above.

Similar to the skirt reinforcement members 1030, 1130, 1230 described above, the skirt reinforcement members 1530, 1530B, 1530C may include a fabric or tissue strip in addition to a suture filament or strand that forms a plurality of stitches. Further, instead of the plurality of skirt reinforcement members 1530, the transcatheter heart valve prosthesis 1500 may include a continuous band or ring that extends 360 ° around the outer surface of the frame 1502. The ring will be attached to the skirt 1512 and may be identical to the skirt reinforcement member 1330 described above. As shown in fig. 15 with respect to skirt reinforcement member 1530, the ring will be positioned over the same row of side openings 1518.

Fig. 16 depicts a perspective view of a transcatheter heart valve prosthesis 1600 according to another aspect of the present disclosure. Transcatheter heart valve prosthesis 1600 includes a stent or frame 1602 and a prosthetic valve component 1608 including at least one leaflet disposed within and secured to frame 1602. Frame 1602 includes a plurality of crowns 1620 and a plurality of struts 1622, wherein each crown 1620 is formed between a pair of opposing struts 1622. Each crown 1620 is a curved segment or bend extending between opposing struts 1622. Frame 1602 is tubular with the plurality of side openings 1618 defined by edges of the plurality of crowns 1620 and the plurality of struts 1622. In one embodiment, the plurality of side openings 1618 may be substantially diamond-shaped.

Frame 1602 includes a skirt 1612 coupled to a surface thereof. More particularly, skirt 1612 is coupled to an inner surface of frame 1602 to line a portion thereof. Alternatively, as known to those of ordinary skill in the art of prosthetic valve construction, the skirt 1612 may be coupled to the outer surface of the frame 1602 to enclose a portion thereof. Skirt 1612 may be formed from the same materials as described above with respect to skirt 112.

The prosthetic valve component 1608 of the transcatheter heart valve prosthesis 1600 is capable of regulating flow therethrough via valve leaflets that can form a replacement valve. Fig. 16 illustrates an exemplary prosthetic valve component having three leaflets 1609, but a single leaflet or mitral leaflet configuration can alternatively be used in embodiments of the present disclosure. As described above with respect to the prosthetic valve component 108, the prosthetic valve component 1608 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen of the frame 1602 when deployed in situ.

Valve leaflets 1609 can be attached to skirt 1612. Skirt 1612 may bulge during valve in situ opening and closing, and leaflets 1609 may contact skirt 1612. Such bulging may undesirably result in contact between the skirt 1612 and the leaflets 1609 of the transcatheter heart valve prosthesis 1600. If the leaflets 1609 of the transcatheter heart valve prosthesis 1600 contact the skirt 1612 during opening and closing, such contact may result in early leaflet tissue wear and early skirt wear. In addition, the large relative movement between the skirt 1612 and the frame 1602 may further result in early skirt wear. Accordingly, the transcatheter heart valve prosthesis 1600 further includes a plurality of skirt reinforcement members 1630. As described above with respect to skirt reinforcement member 730, skirt reinforcement member 1630 reinforces the skirt 1612 material across side opening 1618 of frame 1602 to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both skirt 1612 and leaflets 1609.

In the embodiment of fig. 16, frame 1602 includes exactly three skirt reinforcement members 1630 (but two skirt reinforcement members are not apparent from the view). Skirt reinforcement members 1630 are disposed at the leaflet commissures and are spaced apart at substantially equal intervals around the circumference of the frame 102. However, the placement of skirt reinforcement member 1630 is merely exemplary, and skirt reinforcement member 1630 may be disposed at a different side opening 1618 than depicted in fig. 16.

Fig. 16A is an enlarged view of side opening 1618 of frame 1602 including skirt reinforcement member 1630. Each skirt reinforcement member 1630 spans the side opening 1618 from a first crown or strut edge defining the at least one side opening 1618 to a second crown or strut edge defining the at least one side opening 1618. In the embodiment of fig. 16-16A, skirt reinforcement member 1630 is identical to skirt reinforcement member 730. Each skirt reinforcing member 1630 is a suture filament or strand 1631 that forms a plurality of stitches 1640. Skirt reinforcement member 1630 is directly attached to skirt 1612 along an unsupported portion of skirt 1612 spanning a respective side opening 1618. The plurality of stitches 1640 of skirt reinforcement member 1630 extend or weave through the material of skirt 1612 to ensure that skirt reinforcement member 1630 imparts stretch to skirt 1612 and thereby prevents undesirable bulging of the skirt material. The first end 1632 and the second end 1634 of the skirt reinforcement member 1630 are attached to the frame 1602 such that the skirt reinforcement member 1630 has sufficient tension along its length to minimize radial movement of the skirt 1612 throughout the cardiac cycle.

In fig. 16 and 16A, skirt reinforcement member 1630 extends centrally or centrally over side opening 1618 in a horizontal orientation. However, other placements of the skirt reinforcing member are also contemplated herein. For example, in the embodiment depicted in fig. 16B, skirt reinforcement member 1630B extends centrally or midway over side opening 1618 in a vertical orientation. The first end 1632B of the skirt reinforcement member 1630B is longitudinally offset from the second end 1634B of the skirt reinforcement member 1630B such that the skirt reinforcement member 1630B is relative to the axis L of the frame _A Parallel or substantially parallel. First end 1632B of skirt reinforcement member 1630B is attached to a first crown 1620B defining a respective side opening 1618 and second end 1634B of skirt reinforcement member 1630 is attached to a second or opposite crown 1620B defining a respective side opening 1618 such that skirt reinforcement member 1630B vertically spans side opening 1618.

In another embodiment depicted in FIG. 16C, a first end 1632C of the skirt reinforcement member 1630C is circumferentially offset from a second end 1634C of the skirt reinforcement member 1630C such that the skirt reinforcement member 1630C is relative to the axis L of the frame _A Angled. The first end 1632C of the skirt reinforcement member 1630C is attached to a first edge 1636C defining a respective side opening 1618 and the second end 1634C of the skirt reinforcement member 1630C is attached to a second or opposite edge 1638C defining a respective side opening 1618.

Similar to the skirt stiffening members 1030, 1130, 1230 described above, the skirt stiffening members 1630, 1630B, 1630C may comprise a fabric or tissue strip in addition to the suture filaments or strands forming the plurality of stitches. Further, instead of the plurality of skirt reinforcement members 1630, the transcatheter heart valve prosthesis 1600 may include a continuous band or ring extending 360 ° around the outer surface of the frame 1602. The ring will be attached to skirt 1612 and may be identical to skirt reinforcement member 1330 described above.

Fig. 17 depicts a perspective view of a transcatheter heart valve prosthesis 1700 according to another aspect of the present disclosure. Transcatheter heart valve prosthesis 1700 includes a stent or frame 1702 and a prosthetic valve component 1708 including at least one leaflet disposed within and secured to frame 1702. The frame 1702 includes a plurality of crowns 1720 and a plurality of struts 1722, wherein each crown 1720 is formed between a pair of opposing struts 1722. Each crown 1720 is a curved segment or bend that extends between opposing struts 1722. The frame 1702 is tubular with the plurality of side openings 1718 defined by edges of the plurality of crowns 1720 and the plurality of struts 1722. In one embodiment, the plurality of side openings 1718 may be substantially heart-shaped, with each side opening 1718 formed from six struts 1722 and six crowns 1720.

The frame 1702 includes a skirt 1712 coupled to a surface thereof. More particularly, skirt 1712 is coupled to an inner surface of frame 1702 to line a portion thereof. Alternatively, the skirt 1712 may be coupled to the outer surface of the frame 1702 to enclose a portion thereof, as known to those of ordinary skill in the art of prosthetic valve construction. Skirt 1712 may be formed from the same materials as described above with respect to skirt 112.

The prosthetic valve component 1708 of the transcatheter heart valve prosthesis 1700 is capable of regulating flow therethrough via valve leaflets that can form a replacement valve. Fig. 17 illustrates an exemplary prosthetic valve component having three leaflets 1709, but a single leaflet or mitral leaflet configuration can alternatively be used in embodiments of the present disclosure. As described above with respect to the prosthetic valve component 108, the prosthetic valve component 1708 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen of the frame 1702 when deployed in situ.

The valve leaflet 1709 can be attached to the skirt 1712. The skirt 1712 may bulge during valve in situ opening and closing, and the leaflets 1709 may contact the skirt 1712. Such bulging may undesirably result in contact between the skirt 1712 and the leaflets 1709 of the transcatheter heart valve prosthesis 1700. If the leaflets 1709 of the transcatheter heart valve prosthesis 1700 contact the skirt 1712 during opening and closing, such contact may result in early leaflet tissue wear and early skirt wear. Furthermore, the large relative movement between the skirt 1712 and the frame 1702 may further result in early skirt wear. Accordingly, transcatheter heart valve prosthesis 1700 further includes a plurality of skirt reinforcement members 1730. As described above with respect to skirt reinforcement member 730, skirt reinforcement member 1730 reinforces the skirt 1712 material across side opening 1718 of frame 1702 to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both skirt 1712 and leaflets 1709.

In the embodiment of fig. 17, the frame 1702 includes a row of side openings 1718 around its circumference, and the skirt reinforcement member 1730 extends across or over each side opening 1718 of the row of side openings 1718 around the circumference of the frame 1702. However, it is not required that skirt reinforcement member 1730 be used on each side opening 1718 of the row of side openings 1718 around the circumference of frame 1702. Indeed, the skirt reinforcement member 1730 may be used only on side openings 1718 having skirt material that may contact the leaflets 1709 as the leaflets open and close in situ. According to one aspect of the present disclosure, at least one side opening 1718 must include skirt reinforcement member 1730. Further, the placement of skirt reinforcement member 1730 is merely exemplary, and skirt reinforcement member 1730 may be disposed on side opening 1718 in a different row than depicted in fig. 17.

Fig. 17A is an enlarged view of side opening 1718 of frame 1702 including skirt reinforcement member 1730. Each skirt reinforcement member 1730 spans the side opening 1718 from a first crown or post edge defining the at least one side opening 1718 to a second crown or post edge defining the at least one side opening 1718. In the embodiment of fig. 17-17A, skirt reinforcement member 1730 is identical to skirt reinforcement member 730. Each skirt reinforcement member 1730 is a suture filament or strand 1731 that forms a plurality of stitches 1740. Skirt reinforcement member 1730 is directly attached to skirt 1712 along an unsupported portion of skirt 1712 spanning a respective side opening 1718. The plurality of stitches 1740 of skirt reinforcement member 1730 extend or weave through the material of skirt 1712 to ensure that skirt reinforcement member 1730 imparts stretch to skirt 1712 and thereby prevents undesirable bulging of the skirt material. The first end 1732 and the second end 1734 of the skirt reinforcement member 1730 are attached to the frame 1702 such that the skirt reinforcement member 1730 has sufficient stretch along its length to minimize radial movement of the skirt 1712 throughout the cardiac cycle.

In fig. 17 and 17A, skirt reinforcement member 1730 extends in a horizontal orientation over side opening 1718. However, other placements of the skirt reinforcing member are also contemplated herein. For example, in the embodiment depicted in fig. 17B, skirt reinforcement member 1730B extends centrally or midway over side opening 1718 in a vertical orientation. First end 1732B of skirt reinforcement member 1730B is longitudinally offset from second end 1734B of skirt reinforcement member 1730B such that skirt reinforcement member 1730B is relative to axis L of the frame _A Parallel or substantially parallel. The first end 1732B of the skirt reinforcement member 1730B is attached to a first crown 1720B defining a respective side opening 1718 and the second end 1734B of the skirt reinforcement member 1730 is attached to a second or opposing crown 1720B defining a respective side opening 1718 such that the skirt reinforcement member 1730B spans vertically across the side opening 1718.

In another embodiment depicted in fig. 17C, a first end 1732C of skirt reinforcement member 1730C is circumferentially offset from a second end 1734C of skirt reinforcement member 1730C such that skirt reinforcement member 1730C is relative to axis L of the frame _A Angled. The first end 1732C of the skirt reinforcement member 1730C is attached to a first edge 1736C defining a respective side opening 1718 and the second end 1734C of the skirt reinforcement member 1730C is attached to a second or opposite edge 1738C defining a respective side opening 1718. Adjacent skirt reinforcement members 1730C may have alternating orientations (i.e., diagonally downward and diagonally upward) such that skirt reinforcement members 1730C collectively circumscribe the frame in a zigzag configuration. However, it is not required that adjacent skirt reinforcement members 1730C have alternating orientations, and further, that each side opening 1718 include a skirt reinforcement member as described above.

In another embodiment depicted in FIG. 17D, two skirtsReinforcing member 1730D ₁ 、1730D ₂ Extending in a horizontal orientation over single-sided opening 1718. Each skirt reinforcement member 1730D ₁ 、1730D ₂ Spanning the side openings 1718 from a first crown or post edge defining the side openings 1718 to a second crown or post edge defining the at least one side opening 1718. In the depicted embodiment, each skirt reinforcement member 1730D ₁ 、1730D ₂ Is attached to a first crown 1720 defining a respective side opening 1718 and a second end is attached to a second or opposite crown 1720 defining a respective side opening 1718. In the depicted embodiment, each skirt reinforcement member 1730D ₁ 、1730D ₂ Aligned with each other and having the same orientation, but skirt reinforcement member 11730D ₁ 、1730D ₂ Is merely exemplary, and skirt reinforcement member 1730D ₁ 、1730D ₂ May be disposed in a different orientation than depicted in fig. 17.

Similar to the skirt stiffening members 1030, 1130, 1230 described above, the skirt stiffening members 1730, 1730B, 1730C may also include fabric or tissue strips in addition to the suture filaments or strands forming the plurality of stitches. Further, as an alternative to the plurality of skirt reinforcement members 1730, the transcatheter heart valve prosthesis 1700 may include a continuous band or ring extending 360 ° around the outer surface of the frame 1702. The ring will be attached to skirt 1712 and may be identical to skirt reinforcement member 1330 described above. As shown in fig. 17 with respect to skirt reinforcement member 1730, the ring will be positioned over the same row of side openings 1718.

Fig. 18 depicts a perspective view of a transcatheter heart valve prosthesis 1800 according to another aspect of the present disclosure. Transcatheter heart valve prosthesis 1800 includes a stent or frame 1802 and a prosthetic valve component 1808 including at least one leaflet disposed within and secured to frame 1802. The frame 1802 includes a plurality of crowns 1820 and a plurality of struts 1822, wherein each crown 1820 is formed between a pair of opposing struts 1822. Each crown 1820 is a curved segment or bend extending between opposing struts 1822. The frame 1802 is tubular with the plurality of side openings 1818 defined by the plurality of crowns 1820 and the edges of the plurality of struts 1822. The frame 1802 includes five rows of side openings 1818, labeled row r in FIG. 18 ₁ 、r ₂ 、r ₃ 、r ₄ 、r ₅ . In one embodiment, each row r ₃ 、r ₄ 、r ₅ May be substantially diamond-shaped, with row r ₂ Are each defined by five struts 1822 and are arranged in rows r ₁ Are each defined by six struts 1822.

The frame 1802 includes a skirt 1812 coupled to a surface thereof. More particularly, the skirt 1812 is coupled to an inner surface of the frame 1802 to line a portion thereof. Alternatively, the skirt 1812 may be coupled to an outer surface of the frame 1802 to enclose a portion thereof, as known to those of ordinary skill in the prosthetic valve construction arts. The skirt 1812 may be formed of the same materials as described above with respect to the skirt 112.

The prosthetic valve component 1808 of the transcatheter heart valve prosthesis 1800 is capable of regulating flow therethrough via valve leaflets that can form a replacement valve. Fig. 18 illustrates an exemplary prosthetic valve component having three leaflets 1809, but a single leaflet or mitral leaflet configuration may alternatively be used in embodiments of the present disclosure. As described above with respect to the prosthetic valve component 108, when deployed in situ, the prosthetic valve component 1808 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen of the frame 1802.

Valve leaflets 1809 can be attached to skirt 1812. The skirt 1812 may bulge during valve in situ opening and closing, and the leaflets 1809 may contact the skirt 1812. Such bulging may undesirably result in contact between the skirt 1812 and the leaflets 1809 of the transcatheter heart valve prosthesis 1800. If the leaflets 1809 of the transcatheter heart valve prosthesis 1800 contact the skirt 1812 during opening and closing, such contact may result in early leaflet tissue wear and early skirt wear. In addition, the large relative movement between the skirt 1812 and the frame 1802 may further result in early skirt wear. Accordingly, transcatheter heart valve prosthesis 1800 further includes a plurality of skirt reinforcement members 1830. As described above with respect to skirt reinforcement member 730, skirt reinforcement member 1830 reinforces the skirt 1812 material across the side openings 1818 of frame 1802 to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both the skirt 1812 and leaflets 1809.

In the embodiment of fig. 18, the skirt reinforcement members 1830 span across the row r of side openings 1818 around the circumference of the frame 1802 ₂ And a row r of side openings 1818 around the circumference of the frame 1802 ₄ Or extend over, each of the side openings 1818. However, row r of side openings 1818 around the circumference of frame 1802 is not required ₂ 、r ₄ Skirt stiffening members 1830 are used on each side opening 1818 of the pair. Indeed, the skirt reinforcement member 1830 may be used only on side openings 1818 with skirt material that may come into contact with the leaflets 1809 as the leaflets open and close in situ. According to one aspect of the present disclosure, the at least one side opening 1818 must include a skirt reinforcement member 1830. Further, row r of side openings 1818 ₂ 、r ₄ The placement of skirt reinforcement members 1830 in (a) is merely exemplary, and skirt reinforcement members 1830 may be disposed on side openings 1818 of a different row than depicted in fig. 18.

Fig. 18A is an enlarged view of side opening 1818 of frame 1802 including skirt reinforcement member 1830. Each skirt reinforcement member 1830 spans the side opening 1818 from a first crown or strut edge defining the at least one side opening 1818 to a second crown or strut edge defining the at least one side opening 1818. In the embodiment of fig. 18-18A, skirt reinforcement member 1830 is identical to skirt reinforcement member 730. Each skirt reinforcement member 1830 is a suture filament or strand 1831 forming a plurality of stitches 1840. Skirt reinforcement members 1830 are directly attached to skirt 1812 along the unsupported portion of skirt 1812 spanning the respective side opening 1818. The plurality of stitches 1840 of the skirt reinforcement member 1830 extend or weave through the material of the skirt 1812 to ensure that the skirt reinforcement member 1830 applies tension to the skirt 1812 and thereby prevents unwanted bulging of the skirt material. The first end 1832 and the second end 1834 of the skirt reinforcement member 1830 are attached to the frame 1802 such that the skirt reinforcement member 1830 has sufficient tension along its length to minimize radial movement of the skirt 1812 throughout the cardiac cycle.

In fig. 18 and 18A, skirt reinforcement member 1830 extends centrally or midway over side opening 1818 in a horizontal orientation. However, other placements of the skirt reinforcing member are also contemplated herein. For example, in the embodiment depicted in fig. 18B, skirt reinforcement member 1830B extends centrally or midway over side opening 1818 in a vertical orientation. The first end 1832B of the skirt reinforcement member 1830B is longitudinally offset from the second end 1834B of the skirt reinforcement member 1830B such that the skirt reinforcement member 1830B is relative to the axis L of the frame _A Parallel or substantially parallel. The first end 1832B of the skirt reinforcement member 1830B is attached to a first crown 1820B defining a respective side opening 1818 and the second end 1834B of the skirt reinforcement member 1830 is attached to a second or opposite crown 1820B defining a respective side opening 1818 such that the skirt reinforcement member 1830B vertically spans the side opening 1818.

In another embodiment depicted in fig. 18C, a first end 1832C of skirt reinforcement member 1830C is circumferentially offset from a second end 1834C of skirt reinforcement member 1830C such that skirt reinforcement member 1830C is relative to axis L of the frame _A Angled. The first end 1832C of the skirt reinforcement member 1830C is attached to a first crown 1820 or first edge defining a respective side opening 1818 and the second end 1834C of the skirt reinforcement member 1830C is attached to a second or opposite crown 1820 or second or opposite edge defining a respective side opening 1818. Adjacent skirt reinforcement members 1830C may have an alternating orientation (i.e., diagonally downward and diagonally upward) such that skirt reinforcement members 1830C collectively circumscribe the frame in a zigzag configuration. However, adjacent skirt reinforcement members 1830C are not required to have alternating orientations, and further, each side opening 1818 is not required to include a skirt reinforcement member as described above.

Similar to the skirt stiffening members 1030, 1130, 1230 described above, the skirt stiffening members 1830, 1830B, 1830C may also include a fabric or tissue strip in addition to the suture filaments or strands forming the plurality of stitches. Further, instead of the plurality of skirt reinforcement members 1830, the transcatheter heart valve prosthesis 1800 may include a continuous band or ring extending 360 ° around the outer surface of the frame 1802. The ring will be attached to the skirt 1812 and may be the same as the skirt reinforcement member 1330 described above. As shown in fig. 18 with respect to skirt reinforcement member 1830, the ring may be positioned over the same row of side openings 1818.

While the above embodiments depict various transcatheter valve prostheses having at least one skirt reinforcement member, the skirt reinforcement members described herein may be applied to an abutment prosthesis configured to receive a valve prosthesis therein. Such an abutment prosthesis may include a skirt on a portion thereof that may come into contact with the leaflets of the valve prosthesis received therein as the leaflets open and close in situ. For example, fig. 19 depicts a perspective view of an abutment prosthesis 1900 according to another aspect of the disclosure. The docking prosthesis 1900 includes a stent or frame 1902. The frame 1902 includes a plurality of crowns 1920 and a plurality of struts 1922, wherein each crown 1920 is formed between a pair of opposing struts 1922. Each crown 1920 is a curved segment or bend extending between opposing struts 1922. The frame 1902 is tubular with the plurality of side openings 1918 defined by edges of the plurality of crowns 1920 and the plurality of struts 1922. In one embodiment, the plurality of side openings 1918 may be substantially diamond-shaped.

The frame 1902 includes a skirt 1912 coupled to a surface thereof. More particularly, a skirt 1912 is coupled to an inner surface of the frame 1902 to line a portion thereof. Alternatively, the skirt 1912 may be coupled to an outer surface of the frame 1902 to enclose a portion thereof. The skirt 1912 may be formed of the same materials as described above with respect to the skirt 112.

Referring to fig. 20, the docking prosthesis 1900 is configured to receive a valve prosthesis 2000 therein. The valve prosthesis 2000 includes a frame 2002 and a prosthetic valve component 2008 including at least one leaflet disposed within the frame 2002 and secured thereto. The prosthetic valve component 2008 of the valve prosthesis 2000 is capable of regulating flow therethrough via valve leaflets that can form a replacement valve. The prosthetic valve component 2008 may have three leaflets 2009, but a single leaflet or mitral leaflet configuration may alternatively be used in embodiments of the present disclosure. As described above with respect to prosthetic valve component 108, when deployed in situ, prosthetic valve component 2008 in a closed state is configured to block blood flow in one direction to regulate blood flow through the central lumen of frame 2002. Valve leaflets 2009 can be attached to frame 2002.

The skirt 1912 of the abutment prosthesis 1900 may bulge during in situ opening and closing of the leaflets 2009 and the leaflets 2009 may contact the skirt 1912. Such bulging may undesirably result in contact between the skirt 1912 of the abutment prosthesis 1900 and the leaflets 2009 of the valve prosthesis 2000. If the leaflets 2009 contact the skirt 1912 during opening and closing, such contact may result in early leaflet tissue wear as well as early skirt wear. In addition, the large relative movement between the skirt 1912 and the frame 1902 may further result in early skirt wear. Accordingly, the docking prosthesis 1900 further includes a plurality of skirt reinforcement members 1930. As described above with respect to skirt reinforcement member 730, skirt reinforcement member 1930 reinforces the skirt 1912 material across the side openings 1918 of the frame 1902 to limit radial movement or bulging of the skirt material, thereby minimizing the risk of damage to both the skirt 1912 and the leaflets 2009.

In the embodiment of fig. 19, the frame 1902 includes a row of side openings 1918 around its circumference, and a skirt reinforcement member 1930 extends across or over each side opening 1918 of the row of side openings 1918 around the circumference of the frame 1902. However, it is not required that a skirt reinforcement member 1930 be used on each side opening 1918 of the row of side openings 1918 around the circumference of the frame 1902. Indeed, skirt reinforcement member 1930 may be used only on side openings 1918 that have skirt material that may contact leaflets 2009 as they open and close in situ. In accordance with one aspect of the present disclosure, at least one side opening 1918 must include a skirt reinforcement member 1930. Further, the placement of skirt reinforcement members 1930 is merely exemplary, and skirt reinforcement members 1930 may be disposed over side openings 1918 in a different row than depicted in fig. 19.

Fig. 19A is an enlarged view of side opening 1918 of frame 1902 including skirt reinforcement member 1930. Each skirt reinforcement member 1930 spans the side opening 1918 from a first crown or strut edge defining the at least one side opening 1918 to a second crown or strut edge defining the at least one side opening 1918. In the embodiment of fig. 19-19A, skirt reinforcement member 1930 is identical to skirt reinforcement member 730. Each skirt reinforcing member 1930 is a suture filament or strand 1931 that forms a plurality of stitches 1940. Skirt reinforcement members 1930 are attached directly to the skirt 1912 along unsupported portions of the skirt 1912 spanning the respective side openings 1918. The plurality of stitches 1940 of the skirt reinforcement member 1930 extend or weave through the material of the skirt 1912 to ensure that the skirt reinforcement member 1930 imparts tension to the skirt 1912 and thereby prevents undesirable bulging of the skirt material. The first end 1932 and the second end 1934 of the skirt reinforcement member 1930 are attached to the frame 1902 such that the skirt reinforcement member 1930 has sufficient tension along its length to minimize radial movement of the skirt 1912 throughout the cardiac cycle.

In fig. 19 and 19A, skirt reinforcement member 1930 extends centrally or midway over side opening 1918 in a horizontal orientation. However, other placements of the skirt reinforcing member are also contemplated herein. For example, in the embodiment depicted in fig. 19B, skirt reinforcement member 1930B extends centrally or midway over side opening 1918 in a vertical orientation. The first end 1932B of the skirt reinforcement member 1930B is longitudinally offset from the second end 1934B of the skirt reinforcement member 1930B such that the skirt reinforcement member 1930B is relative to the axis L of the frame _A Parallel or substantially parallel. The first end 1932B of the skirt reinforcement member 1930B is attached to a first crown 1920B defining a respective side opening 1918, and the second end 1934B of the skirt reinforcement member 1930 is attached to a second or opposite crown 1920B defining a respective side opening 1918, such that the skirt reinforcement member 1930B vertically spans the side opening 1918.

In another embodiment depicted in fig. 19C, a first end 1932C of the skirt reinforcement member 1930C is circumferentially offset from a second end 1934C of the skirt reinforcement member 1930C such that the skirt reinforcement member 1930C is relative to the axis L of the frame _A Angled. First skirt reinforcement member 1930CThe ends 1932C are attached to a first edge 1936C defining a respective side opening 1918, and the second ends 1934C of the skirt reinforcement members 1930C are attached to a second or opposite edge 1938C defining a respective side opening 1918. Adjacent skirt reinforcement members 1930C may have alternating orientations (i.e., diagonally downward and diagonally upward) such that skirt reinforcement members 1930C collectively circumscribe the frame in a zigzag configuration. However, adjacent skirt reinforcement members 1930C are not required to have alternating orientations, and further, each side opening 1918 is not required to include a skirt reinforcement member as described above.

Similar to the skirt stiffening members 1030, 1130, 1230 described above, the skirt stiffening members 1930, 1930B, 1930C may include fabric or tissue strips in addition to the suture filaments or strands forming the plurality of stitches. Further, instead of the plurality of skirt reinforcement members 1930, the docking prosthesis 1900 may include a continuous band or ring extending 360 ° around the outer surface of the frame 1902. The ring will be attached to the skirt 1912 and may be identical to the skirt reinforcement member 1330 described above. As shown in fig. 19 with respect to skirt reinforcement member 1930, the ring will be positioned over the same row of side openings 1918.

It should be understood that the various aspects disclosed herein may be combined in different combinations than specifically presented in the specification and drawings. It should also be appreciated that, according to an example, certain acts or events of any of the processes or methods described herein can be performed in a different order, may be added, combined, or omitted entirely (e.g., all of the described acts or events may not be necessary to implement the techniques). Furthermore, while certain aspects of the present disclosure are described as being performed by a single module or unit for clarity, it should be understood that the techniques of the present disclosure may be performed by a unit or combination of modules associated with, for example, a medical device.

Claims

1. A prosthesis having a radially expanded configuration and a radially compressed configuration, the prosthesis comprising:

a frame comprising a plurality of crowns and a plurality of struts, wherein each crown is formed between a pair of opposing struts, wherein edges of the plurality of crowns and the plurality of struts define a plurality of side openings;

a skirt coupled to a surface of the frame, wherein the skirt extends over at least one of the plurality of side openings of the frame; and

a skirt reinforcement member spanning the at least one side opening from a first crown or post edge defining the at least one side opening to a second crown or post edge defining the at least one side opening of the frame, the skirt reinforcement member having a first end, a second end and a length therebetween, wherein the first end of the skirt reinforcement member is attached to the first crown or post edge and the second end of the skirt reinforcement member is attached to the second crown or post edge, and wherein the skirt reinforcement member is attached to the skirt along an unsupported portion of the skirt spanning the at least one side opening.

2. The prosthesis of claim 1, wherein the skirt reinforcement member comprises a suture forming a plurality of stitches.

3. The prosthesis of claim 1, wherein the skirt reinforcement member comprises tissue.

4. The prosthesis of claim 1, wherein the skirt reinforcement member comprises a fabric.

5. The prosthesis of claim 1, wherein one end of the frame includes a row of side openings around a circumference of the frame, the row including six to nine side openings.

6. The prosthesis of claim 1, wherein the first end of the skirt reinforcement member is circumferentially offset from the second end of the skirt reinforcement member such that the skirt reinforcement member is angled relative to the axis of the frame.

7. The prosthesis of claim 1, wherein the first end of the skirt reinforcement member is circumferentially aligned with the second end of the skirt reinforcement member such that the skirt reinforcement member extends substantially perpendicularly relative to the axis of the frame.

8. The prosthesis of claim 7, wherein the at least one side opening comprises a maximum width, and the skirt reinforcement member spans across the at least one side opening at the maximum width.

9. The prosthesis of claim 7, wherein the frame comprises a plurality of nodes, each node being a region where two crowns of the plurality of crowns of the frame meet, and wherein the skirt reinforcement member spans the at least one side opening from one node to another node.

10. The prosthesis of claim 1, wherein the frame includes a row of side openings around a circumference of the frame, and a skirted reinforcing member spans each side opening of the row of side openings around the circumference of the frame.

11. The prosthesis of claim 1, wherein the frame is an inner frame, and the prosthesis further comprises an outer frame coupled to the inner frame, the outer frame having a diameter greater than the inner frame.

12. The prosthesis of claim 1, wherein the prosthesis is a heart valve prosthesis and the prosthesis further comprises a prosthetic valve component disposed within and secured to the frame, the prosthetic valve configured to block blood flow in one direction to regulate blood flow through a central lumen of the frame.

13. The prosthesis of claim 1, wherein the heart valve prosthesis is configured to be placed in situ within a mitral valve.

14. A prosthesis having a radially expanded configuration and a radially compressed configuration, the prosthesis comprising:

a skirt reinforcement member circumscribing an outer surface of the frame, the skirt reinforcement member having a diameter substantially the same as a diameter of the frame when the prosthesis is in the radially expanded configuration, wherein the skirt reinforcement member is attached to the skirt along an unsupported portion of the skirt spanning the at least one of the plurality of side openings of the frame, and wherein the skirt reinforcement member is not directly attached to the frame.

15. The prosthesis of claim 14, wherein the skirt reinforcement member is a ring of elastomeric material.

16. The prosthesis of claim 14, wherein the at least one of the plurality of side openings is substantially diamond-shaped.

17. The prosthesis of claim 14, wherein one end of the frame includes a row of side openings around a circumference of the frame, the row including six to nine side openings.

18. The prosthesis of claim 14, wherein the frame is an inner frame, and the prosthesis further comprises an outer frame coupled to the inner frame, the outer frame having a diameter greater than the inner frame.

19. The prosthesis of claim 14, wherein the prosthesis is a heart valve prosthesis and the prosthesis further comprises a prosthetic valve component disposed within and secured to the frame, the prosthetic valve configured to block blood flow in one direction to regulate blood flow through a central lumen of the frame.

20. The prosthesis of claim 19, wherein the heart valve prosthesis is configured to be placed in situ within a mitral valve.